NCT01022762

Brief Summary

This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood glucose lowering effect and the safety profile of repaglinide given alone compared to gliclazide given alone in Chinese subjects with type 2 diabetes who never have been treated with oral anti-diabetic drugs (OADs). This study also investigates the augment effect of repaglinide on the phases of insulin secretion as a subgroup study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
440

participants targeted

Target at P75+ for phase_4 diabetes

Timeline
Completed

Started Nov 2009

Shorter than P25 for phase_4 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

November 26, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 1, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

December 29, 2011

Completed
Last Updated

July 9, 2014

Status Verified

June 1, 2014

Enrollment Period

1 year

First QC Date

November 26, 2009

Results QC Date

November 24, 2011

Last Update Submit

June 25, 2014

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Change in Glycosylated Haemoglobin (HbA1c)

    Week 0, week 16

Secondary Outcomes (10)

  • Change in Fasting Plasma Glucose

    Week 0, week 16

  • Change in 2-hour Postprandial Plasma Glucose (PPG) Over a Standard Meal

    Week 0, week 16

  • Percentage of Participants Achieving the Treatment Target of HbA1c Below or Equal to 6.5%

    Week 16

  • Change in Fasting Serum Free Fatty Acid (FFA) From Baseline

    Week 0, week 16

  • Change in 2-hour Postprandial Serum Free Fatty Acid (FFA) Over a Standard Meal

    Week 0, week 16

  • +5 more secondary outcomes

Study Arms (2)

repaglinide

ACTIVE COMPARATOR

1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily

Drug: repaglinide

gliclazide

ACTIVE COMPARATOR

80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily

Drug: gliclazide

Interventions

repaglinideDRUG

Individually adjusted dose for 16 weeks

repaglinide
gliclazideDRUG

Individually adjusted dose for 16 weeks

gliclazide

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes
  • Oral anti-diabetic drug (OAD) naïve (unsystematic OAD treatment 6 months prior to this trial is allowed)
  • Insulin naïve (less than 1 week of daily use of insulin therapy before trial start is allowed)
  • Lipid-lowing agent naïve
  • HbA1c: 6.5-8.5%
  • Fasting glucose: 6.1-13.0 mmol/L (110-234 mg/dl)
  • Body Mass Index (BMI): 20-35 kg/m\^2
  • Be able and willing to perform self-monitored plasma glucose (SMPG)
  • Be able and willing to eat 3 main meals per day
  • Only applicable to subjects who will participate in the subgroup study: Be able and willing to perform and complete IVGTT (intravenous glucose tolerance test) at additional visits

You may not qualify if:

  • Known or suspected allergy to repaglinide, gliclazide, or related products (for example sulfonamide or other sulphonylureas (SUs)), or any of the excipients in the study drugs
  • Previous participation in this study
  • Participation in a study of another investigational drug within 1 month prior to study start

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Shanghai, Shanghai Municipality, 200025, China

Location

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

repaglinideGliclazide

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsSulfonylurea CompoundsUreaBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur Compounds

Results Point of Contact

Title
Public Access to Clinical Trials
Organization
Novo Nordisk A/S
clinicaltrials@novonordisk.com

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2009

First Posted

December 1, 2009

Study Start

November 1, 2009

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

July 9, 2014

Results First Posted

December 29, 2011

Record last verified: 2014-06

Locations

CN(1)